natural pharmaceuticals derived From Cannabis and other medicinal plants
Message: Tetra Bio-Pharma Announces the Completion of its Phase 1 Safety Report to Health Canada and Launches the Preparation of a Phase III Clinical Trial...
Tetra Bio-Pharma Announces the Completion of its Phase 1 Safety Report to Health Canada and Launches the Preparation of a Phase III Clinical Trial for PPP001 with Sante Cannabis
OTTAWA, ONTARIO--(June 7, 2017) - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (CSE:TBP)(CSE:TBP.CN)(CNSX:TBP)(OTCQB:TBPMF), and PhytoPain Pharma (PPP), a subsidiary of Tetra Bio-Pharma, is pleased to announce that it has submitted a report on the safety and pharmacokinetics of PPP001 (smokeable marijuana) to Health Canada. The Company is also launching the preparation of a Phase III clinical trial in collaboration with Québec's leading medical cannabis clinic, Santé Cannabis. PPP001 is the first smokeable cannabis drug product being developed for the treatment of late-stage cancer patients with pain. According to Global Pain Management, approximately 50% of cancer patients suffer from pain and more than 600,000 of these patients suffer from moderate-to-severe pain. In the USA, there are over 4 million cancer patients and this pain market is valued at over US$5 billion.
After a detailed review of the clinical data, the Company is pleased to announce that the safety data met its expectations and that the pharmacokinetic data demonstrated that the inhalation of PPP001 achieved the targeted plasma levels of THC that could potentially achieve pain relief in cancer patients. The Phase I trial provides the key information required by the medical experts of Santé Cannabis to design a Phase III clinical trial for cancer patients. The Company expects to launch the Phase III clinical trial by Q4/17 - Q1/18.
"Shareholders should be proud to know how quickly we have moved through the Phase I trial and we are now progressing on an accelerated path to the Phase III trial which is, relatively speaking, a tremendous accomplishment for the organization and a testament of the excellent work undertaken by Dr. Chamberland and his team," said Andre Rancourt CEO of Tetra Bio-Pharma. "Tetra has achieved a significant milestone in the execution of its business plan of becoming a global leader in pharmaceutical cannabis."
"The development of PPP001 for patients with advanced cancer is an important commitment for Tetra. Cancer patients suffer from severe pain which is often accompanied by depression and insomnia. Medical marijuana has been shown to help patients beyond the immediate benefit of pain relief. With the expertise of Santé Cannabis, we expect to demonstrate the clinical benefits of PPP001 on the quality of life of advanced cancer patients. Importantly, our clinical program will also address the potential of PPP001 to reduce the reliance on opioids for management of severe pain. The Company will continue to maintain a transparent and direct line of communication with Health Canada (Therapeutic Products Directorate and Controlled Drug Substances) and the U.S. FDA to ensure that we address the issues required for drug approval. PPP001 is about patients first," commented Dr. Chamberland CSO of Tetra Bio-Pharma.
In late May 2017, Tetra had a pre-submission consultation meeting with the Therapeutic Products Directorate (TPD) of Health Canada to brief the agency on the safety findings and pharmacokinetics of PPP001, and to discuss its clinical development program leading to the submission of a New Drug Submission for a first indication in advanced cancer patients with pain. Health Canada provided feedback and guidance on Tetra's clinical development program and the proposed Phase III clinical trial.
Tetra and Santé Cannabis have focused the clinical development on a first indication in patients with advanced cancer. The Phase III clinical trial will be performed by the medical team of Santé Cannabis. "Medical cannabis has clear potential for the treatment of cancer pain that is partially or not responsive to opioid therapies and other analgesics," states Dr. Antonio Vigano, lead trial physician and Research Director of Santé Cannabis. "It is our obligation to confirm the safety, efficacy and tolerability of PPP001 and to ensure that we are helping cancer patients by offering every possible tool to control pain and improve quality of life."
The Company will be completing the research required to ensure that PPP001 conforms to the chemistry and manufacturing requirements under the Food and Drug regulations to secure its Notice of Compliance and a Drug Identification Number (DIN).
About Tetra Bio-Pharma:
Tetra Bio-Pharma is a multi subsidiary publicly traded company (CSE:TBP) (OTCQB:TBPMF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio-Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
Source: Tetra Bio-Pharma
The Canadian Securities Exchange ("CSE") has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Inc.
Vice President, IR & Corporate Communications
(514) 360-8040 Ext. 203
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